MAUDE Adverse Event Report: EXACTECH, INC. TRULIANT TIB IMP PS INSERT SZ 3 11MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED

Model Number	02-022-35-3011
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Failure of Implant (1924); Pain (1994)
Date of Event	10/27/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported, this male patient had an initial left tka on (b)(6) 2021.The surgeon performed a poly swap on a logic cc knee.The patient was complaining of pain.There was no breakage of device or surgical delay/prolongation.The patient was last known to be in stable condition following the event.
Additional Manufacturer Narrative
Pending investigation.
Additional Manufacturer Narrative
H3: based on review of all available information, there is no evidence to suggest that the reported event is related to any design or manufacturing issues.The cause of pain and the subsequent revision cannot be conclusively determined; however, it is most likely related to patient conditions as associated with the interaction between the implanted device and the patient due to patient illness, bilateral knee replacements, unique anatomy, or other condition that impacts the performance of the device.D10: 6608367, 02-010-06-0230 - logic cc femoral size 3, left; 5777187, 02-012-50-3011 - logic fit/rbk augment 1/2 block sz 3, 5mm; 6571844, 02-012-61-2000 - logic offset stem ext coupler 2mm; 6806530, 02-012-61-2000 - logic offset stem ext coupler 2mm; 5738393, 02-012-64-1280 - tru fluted stm ext 12mm x 80mm blast; 5642075, 02-012-64-1412 - tru fluted stm ext 14mm x120mm blast; 7021049, 02-022-45-3030 - truliant tib fit tray cem sz 3f / 3t; 6605756, 204-70-00 - tibial stem ext.Screw; 7004345, 208-05-03 - cc distal fem augment sz 3, 5mm; 7004348, 208-05-03 - cc distal fem augment sz 3, 5mm.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay corrected information.The following sections were corrected: b1, b2, d6b: remove erroneous date from initial-explant date unknown), f6 & f9 (remove erroneously entered dates from initial report), d8, g2 (correcting initial report), h6: clinical code, medical device problem code, component code, investigation findings, investigation conclusion.If any further information is obtained that would change or alter any information provided, a supplemental report will be filed accordingly.

• Brand Name: TRULIANT TIB IMP PS INSERT SZ 3 11MM
• Common Device Name: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer (Section G): EXACTECH, INC.; 2320 nw 66th ct; gainesville FL 32653
• Manufacturer Contact: kate jacobson ; 2320 nw 66th ct; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 15848567
• Report Number: 1038671-2022-01499
• Device Sequence Number: 6525674
• Product Code: JWH
• UDI-Device Identifier: 10885862304278
• UDI-Public: 10885862304278
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K152170
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/02/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 08/01/2026
• Device Model Number: 02-022-35-3011
• Device Catalogue Number: 02-022-35-3011
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 11/02/2022
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/02/2022
• Supplement Date Received by Manufacturer: 11/29/2022; 01/21/2026
• Initial Report FDA Received Date: 11/22/2022
• Supplement Report FDA Received Date: 12/13/2022; 02/02/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/14/2018
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10.; SEE H10.
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Male